Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT05481216
Eligibility Criteria:
Inclusion Criteria:
* • Cases (PLWHIV + COVID-19)
1. Any gender
2. At least 18 years of age
3. Documented HIV-1 infection
4. Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021
* Controls (COVID-19)
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1. Any gender
2. At least 18 years of age
3. No documented HIV-1 infection
4. Confirmed SARS-CoV-2 infection by documented, or patient-reported, positive result on PCR testing of a nasopharyngeal or respiratory sample, before 1st April 2021
5. Meet the matching criteria
For comparing PLWHIV \& COVID-19 versus HIV seronegative COVID-19 patients, a 1:1 matching will be performed according to the following criteria:
* Age (+/- 5 years)
* Sex
* Ethnicity (where available)
* Month of COVID-19 diagnosis (+/- 2 months)
* COVID-19 diagnosis inpatient OR
* COVID-19 diagnosis outpatient (ambulatory)
* Controls (PLWHIV)
1. Any gender
2. At least 18 years of age
3. Documented HIV-1 infection
4. No evidence of SARS-CoV-2 infection
5. Meet the matching criteria
For comparing PLWHIV \& COVID-19 versus PLWHIV without COVID-19, a 1:2 matching for similar risk of acquiring COVID-19 will be performed according to the following criteria:
* Age (+/- 5 years)
* Sex
* Ethnicity (where available)
Exclusion Criteria
For cases (PLWHIV + COVID-19) and for COVID-19 only controls:
* COVID-19 diagnosed based on clinical criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05481216
Study Brief:
Protocol Section:
NCT05481216